The Pediatric Acute Leukemia (PedAL) Screening Trial - A Study to Test Bone Marrow and Blood in Children With Leukemia That Has Come Back After Treatment or Is Difficult to Treat - A Leukemia & Lymphoma Society and Children's Oncology Group Study
S
Sandeep Batra, MD
Primary Investigator
Administratively Closed
22 years or below
All
Phase
1/2
960 participants needed
2 Locations
Brief description of study
What is the purpose of this study?
This study aims to use clinical and biological characteristics of acute leukemias to screengibility for available pediatric leukemia sub-trials. Testing bone marrow and
blood from patients with leukemia that has come back after treatment or is difficult to treaty provide information about the patient's leukemia that is important when deciding how to
best treat it, and may help doctors find better ways to diagnose and treat leukemia inhildren, adolescents, and young adults.
PRIMARY OBJECTIVES:
I. To utilize clinical and biological characteristics of
acute leukemias to screen forgibility for available phase I/II Pediatric
Acute Leukemia (PedAL) sub-trials.
II. To maintain a longitudinal and comprehensive registry
from relapse in children and youngdults with recurrent and refractory
leukemia.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
What will happen during the study?
- Patients undergo collection of blood and/or bone marrow samples at baseline, end of treatmentycle(s), and at relapse/refractory disease status (if applicable).
- After completion of study, patients are followed up every 3 months for 2 years, and thenvery 6 months for 3 years.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Riley, Recurrent Acute Lymphoblastic Leukemia, Recurrent Acute Myeloid Leukemia, Recurrent B Acute Lymphoblastic Leukemia, Recurrent Mixed Phenotype Acute Leukemia, Recurrent T Acute Lymphoblastic Leukemia, Refractory Acute Myeloid Leukemia, Refractory Mixed Phenotype Acute Leukemia, Therapy-Related Acute Myeloid Leukemia
-
Age: 22 years or below
-
Gender: All
Inclusion Criteria:
- Patients must be less than 22 years of age at the time of study enrollment
- Patient must have one of the following:
- Patient has known or suspected relapsed/refractory (including primary refractory)
AML
- This includes isolated myeloid sarcoma
- Patient has known or suspected relapsed/refractory (including primary refractory)
myeloid leukemia of Down syndrome
- Patient has known or suspected relapsed ALL that meets one of the following
- Second or greater B-ALL medullary relapse, excluding KMT2Ar.
- Any first or greater B-ALL medullary relapse involving KMT2Ar.
- Any first or greater T-ALL medullary relapse with or without KMT2Ar.
- Patient has known or suspected relapsed/refractory (including primary refractory)
mixed phenotype acute leukemia
- Patient has known or suspected de novo or relapsed/refractory (including primaryy) treatment related AML
- Patient has known or suspected relapsed/refractory (including primary refractory)
AML
- All patients and/or their parents or legal guardians must sign a written informed
consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute(NCI) requirements for human studies must be met
Updated on
13 Dec 2024.
Study ID: APAL2020SC, PHO-COG-APAL2020SC, 14242
